MAUDE Adverse Event Report: NEOTRACT, INC. NEOTRACT UROLIFT SYSTEM

Model Number	UROLIFT SYSTEM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Urinary Retention (2119); Urinary Tract Infection (2120); Heart Failure/Congestive Heart Failure (4446)
Date of Event	07/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022, neotract was made aware of a published clinical article that reported a patient who underwent a prostatic urethral lift (pul) procedure on an unspecified date.Following the procedure, the patient required self-catheterization and was reported to have developed recurrent urinary tract infections, treated with oral antibiotics.The patient is reported to have developed shortness of breath and activity intolerance that resolved with rest, and experienced weight loss secondary to decreased appetite.Upon further evaluation by cardiologist, he was found to have tachycardia and bilateral lower extremity edema.The patient was admitted to the hospital for congestive heart failure and treated with iv diuretics.During this hospitalization, he was diagnosed with infective endocarditis, treated with iv antibiotics and required mitral and aortic valve replacement.The patient was reported as having a near complete return to baseline health.

• Brand Name: NEOTRACT UROLIFT SYSTEM
• Common Device Name: UROLIFT SYSTEM
• Manufacturer (Section D): NEOTRACT, INC.; hopyard road; pleasanton CA 94588
• Manufacturer (Section G): NEOTRACT, INC.; 4155 hopyard road; pleasanton CA 94588
• Manufacturer Contact: brian gall ; 4155 hopyard road; pleasanton, CA 94588 ; 9253296547
• MDR Report Key: 15256840
• Report Number: 3015181082-2022-00021
• Device Sequence Number: 17810619
• Product Code: PEW
• UDI-Device Identifier: 00814932020001
• UDI-Public: 00814932020001
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K193269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: UROLIFT SYSTEM
• Device Catalogue Number: AN00155
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2022
• Initial Report FDA Received Date: 08/19/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Race: White